FDA Advisory Committee Gives Vote of Confidence for Full Approval of Pfizer’s COVID-19 Pill, Paxlovid

The U.S. Food and Drug Administration (FDA) received a vote of confidence from its independent advisory committee on Thursday in support of full approval of Pfizer’s COVID-19 pill, Paxlovid.

The panel of outside experts voted 16-1 that the benefits of the drug outweigh the risks for the treatment of mild to moderate Covid-19 in adults who are at high risk for severe disease, including hospitalization and death.

Dr. Richard Murphy, a member of the advisory committee, said, “We still have many groups that stand to benefit from Paxlovid, including unvaccinated persons, under-vaccinated persons, the elderly and the immuno-compromised.”

Since it became available under emergency use authorization in December 2021, more than 8 million people in the US have received Paxlovid, a combination of the drugs nirmatrelvir and ritonavir.

The FDA must now conduct its own review before the antiviral medication is fully approved. The agency typically follows the recommendations of its independent advisory committee.

Paxlovid is the first pill approved for the treatment of COVID-19 in the US. It is expected to help reduce the number of hospitalizations and deaths due to the virus. The FDA is expected to make a decision on full approval of the drug in the coming weeks.